FDA.reportPublic FDA data

NA

Primary DI
16938119388249
Brand
NA
Company
Henan Tuoren Medical Device Co.,Ltd.
Model
Oropharyngeal airway(Model:9.0#)
Device description
Oropharyngeal airway(Model:9.0#)
Published
2022-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938119388249PackageGS150In Commercial Distribution
26938119388253PackageGS14In Commercial Distribution
06938119388235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693811938824916938119388249
2693811938825326938119388253
06938119388235069381193882356938119388235

GMDN Terms#

Term, Definition table
TermDefinition
Oropharyngeal airway, single-useA curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526982680
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938119329429NABending edge:0#2022-11-18
06938119329450NABending edge:1#2022-11-18
06938119329481NABending edge:2#2022-11-18
06938119329511NABending edge:3#2022-11-18
06938119329542NABending edge:4#2022-11-18
06938119329573NABending edge:5#2022-11-18
06938119329603NA Detachable model:3#2022-11-18
06938119329634NA Detachable model:4#2022-11-18
06938119329665NA Detachable model:5#2022-11-18
06938119331071NAInfant2022-11-18
06938119331101NATracheotomy 2022-11-18
06938119359020NAMedical Laryngeal Mask Airway(Normal model:1.0# )2022-11-19
06938119359051NAMedical Laryngeal Mask Airway(Normal model:1.5# )2022-11-19
06938119359099NAMedical Laryngeal Mask Airway(Normal model:2.0# )2022-11-19
06938119359136NAMedical Laryngeal Mask Airway(Normal model:2.5# )2022-11-19
06938119359174NAMedical Laryngeal Mask Airway(Normal model:3.0# )2022-11-19
06938119359211NAMedical Laryngeal Mask Airway(Normal model:4.0# )2022-11-19
06938119359259NAMedical Laryngeal Mask Airway(Normal model:5.0# )2022-11-19
06938119359860NABlockbuster Laryngeal Mask Airway(model:1.0# )2022-11-19
06938119359907NABlockbuster Laryngeal Mask Airway(model:1.5# )2022-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmASSOMEDIKA, OOOCAE2026-05-27
10197344165605MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165612MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165629MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165636MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165643MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165650MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165667MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165674MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10801902154054LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902154061LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902154078LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902154085LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902153972LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902153989LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902153996LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154009LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154016LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154023LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154030LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154047LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154092LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154108LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154115LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10889483214107Air-Q®AIRLIFECAE2025-02-10
10889483214114Air-Q®AIRLIFECAE2025-02-10
10889483214121Air-Q®AIRLIFECAE2025-02-10
10889483480328Air-Q3®AIRLIFECAE2025-02-10